DMF to declare the status quo of China's API exports
U.S. FDA Drug Master Files (DrugMasterFile referred to as the DMF file) is a necessary qualification documents for the chemical raw materials, intermediates, excipients, supplies, and medical drug packaging, pharmaceutical raw materials entering the United States the door.
25 years more than 300 of DMF is
U.S. FDA since 1940 as of the end of December 2004, has been awarded the DMS file registration number a total of 17,894 pieces currently in force, there are 7,160. Which, from the end of 1980, China began to get the registration number of 317 raw pharmaceuticals and intermediates, and today has received DMF registration of documents currently valid file number 200. Health Network tracking survey shows that, in 2004, the annual total of 38 of our products have DMF file number.
API products in China was first DMF file is December 31, 1980, Taiyuan, Shanxi pharmaceutical meprobamate (now lapsed). History when the file number up to 1998 A total of 47 files registration number is still valid 31. Beginning in 2002, China passed the gradual increase in the number of the past three years to obtain a valid document number 96. Be seen that the Chinese enterprises in the journey towards the international market, are beginning to realize the importance and necessity of quality and management, and in practice with the international standardization of market practice.
By the DMF is the dominant enterprise, superior products
DMF file number of Chinese enterprises who are the product of the most competitive enterprises of the domestic. For example, Hisun Pharmaceutical has a DMF file number (24), its product lovastatin, simvastatin, America cutting statins, pravastatin and anti-tumor antibiotics and so on in the ranks; Shandong Xinhua Pharmaceutical of antipyretic and analgesic main production enterprises, ibuprofen, caffeine, aspirin, trimethoprim pyrimidine DMF file number; domestic antibiotics in key manufacturing enterprises the Hebei Run pharmaceutical, its products - the ACA ,6-APA and penicillin G potassium and amoxicillin are the last two years the DMF file number.
China obtained 200 files, antibiotics, anticancer and antipyretic analgesics largest proportion, 27%, 15% and 8%, respectively, these three products represent the advantages of China's raw material drug production category, also see the advantage of China's pharmaceutical raw materials more basic type, bulk volume, low value-added areas.
China's access to the common name of the DMF is 134 kinds of these products to the anti-infective, clindamycin hydrochloride as many as 10, followed by antipyretic analgesic paracetamol 8, the anticancer drugs paclitaxel 6. Therefore, we also recommend to avoid the concentration is too high the product, to reduce the risk of competition.
Quality, credibility and profits along with all l
"Pass" into the U.S. market in DMF registration number to obtain the United States by the FDA site inspection benefits are obvious, not only bulk drugs intermediates, and because the FDA the authority of the pharmaceutical industry is recognized by the countries in the world, it the approval also of vital importance for access to the entire international market. China has become a big country of the world's raw material drug production, while the United States is the largest imports of bulk drugs.
Therefore, the U.S. market should become the most attractive of the many API manufacturer in China market. Sales of nearly $ 10 billion a year U.S. pharmaceutical preparations, their production 70% of the used raw materials imported from foreign countries, including India and China are the main countries of origin. But we have seen, India, Japan, DMF is the number of far more than China, 622 and 425, respectively, our gap is still very clear.
In fact, this is the VC investors often have to ask themselves and their partner. More and more venture capital funds and institutional investors in the reflection, whether it is worth to continue to soak in the sea of biopharmaceutical fishing needle. This is also the most discussed topic in the recent global M & A Summit. Executives and investment horizon of the risk business from biotechnology clear shift in the more hype the concept of social network world. FACEBOOK is not listed already as high as $ 50 billion market value, this is a matter of ordinary biopharmaceutical company dreamed of but never achieve.
"Imagine, one in the early development stage biopharmaceutical company to go IPO road, need to invest 5 to 9 years to revenue and profitability for most investors today are difficult to accept." Peter Salomon analyst Frederick Frank said. For the biopharmaceutical company's IPO market has not completely shut down, but also dying.
Barclays Capital Drew birch equally pessimistic: "Look at the venture capital funds of other attractive options, if the investment in social networks, may be listed in the next 12 months; biotechnology class creativity and ideas, wait eight years to become the FDA approved the products to be full, and then the most important things to spend money to do clinical trials, these clinical trials are often high-risk, no one can ensure success. "Today's drug discovery environment, do to effective security may be okay, but it takes guts and courage to do better than the new drugs and old drug patent expiration.
In recent months, the biopharmaceutical listed one after another, have paid a high price. If you have enough money, they may not wish to low-cost listing. From the listed companies, biopharmaceutical companies have to cut its stock issue price, increased the number of shares issued, in order to raise the funds needed, because the IPO is their last hope, otherwise you will be big medicine The factory cheap eat.
Another direct benefits to the DMF file number is to increase the "worth" of the product. DMF file number represents a high-quality, good management, its products and manufacturers that may be in the industry for a very wide reputation in the international market is often worth double.
In the past, many pharmaceutical manufacturers did not pass the FDA's cGMP certification, resulting in their products can not directly import U.S.. Although there are some domestic pharmaceutical agents re-exported or to be evolving indirectly enter the United States, but most of the products lose the opportunity to stand up to enter the U.S. mainstream market.
Now, more and more enterprises have realized the importance and necessity of access to international markets, and begin to prepare for the products into the European and American markets. China is a major exporter of raw material drug production, the bulk drugs to be exported to the United States, reported that the work of DMF file review is critical.